On October 11th, 2019, the California Environmental Laboratory Accreditation Program (ELAP) published notice of its proposed regulations concerning the accreditation of environmental laboratories. The proposed regulations make changes to California’s state laboratory accreditation program and affect the requirements that the environmental testing laboratories must meet to analyze environmental samples for regulatory purposes in California. ELAP has called for the incorporation of the 2016 TNI Standard with two California-specific exceptions.
The Initial Statement of Reasons for ELAP’s proposed regulations cited findings from the external review conducted by the Expert Review Panel (ERP), as well as internal reviews of the program by executive management at the State Water Board. The 2015 findings included inadequate accreditation standards, organizational issues, late and ineffective assessments, a lack of financial resources, and lack of enforcement constituted the major program deficiencies. Although great strides have been made in most areas since the reorganization of ELAP, the overarching problem plaguing ELAP continues to be the “woefully outdated and inadequate requirements in the current regulations.” For this reason, ELAP has proposed regulations that will best address existing obscurities, the inconsistency of lab assessments, and the general lack of trust in analytical data generated by ELAP accredited labs as a result of the program’s past deficiencies.
ELAP engaged in a multi-year, stakeholder-involved process to evaluate the accreditation standard options and select the best accreditation standard for the program. The State Water Board considered two alternative accreditation standards to incorporate into the proposed regulations: (1) a state-created accreditation standard and (2) a modified version of an existing accreditation standard. These alternatives were rejected, however, as the State Water Board concluded they lack effectiveness and credibility, and merely represent the status quo. The State Water Board further concluded that “the 2016 TNI Standard is consensus-based, approved by the USEPA, and technically superior to the alternative accreditation standards.”
The 2016 TNI Standard is a quality management system-based accreditation standard, which requires processes and procedures for the management of laboratory operations to assure the quality of the test results it generates. However, two exceptions to the 2016 TNI Standard have been granted. The exceptions are in relation to the frequency of required proficiency testing (PT) of laboratories and the minimum credential requirements of a technical manager (laboratory director).
The publication of ELAP’s notice of its proposed regulations also commenced the public comment period, which will conclude on December 20, 2019. A public hearing to receive written and oral comments will be held on December 18, 2019, and the State Water Board will consider adoption of the proposed ELAP regulations at the State Water Board meeting on March 17, 2020.
For more information, visit CA ELAP’s regulations webpage.
Babcock Laboratories is CA ELAP accredited and also maintains NELAP accreditation—which endorses the 2016 TNI Standard—through the State of Oregon (ORELAP). View our certifications.